BEUDAMED
    FDA Recall Terminated

    MOSAIQ Oncology Information Systems interfaced to Elekta Treatment machines. An image enabled electronic medical record system used for oncology workflow management. Manufactured by: Impac Medical Systems 100 Mathilda Place, 5th floor Sunnyvale, Ca 94086

    Recall: Z-1944-2012 · Initiated June 8, 2012

    Recall

    Recall Number
    Z-1944-2012
    Event Number
    62302
    Firm
    Impac Medical Systems Inc
    FEI Number
    1000123805
    Product Code
    IYE
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    June 8, 2012
    Posted
    July 6, 2012
    Terminated
    June 19, 2013
    Address
    100 Mathilda Place, Floor 5th, Sunnyvale, CA, 94086-6076

    Description

    MOSAIQ Oncology Information Systems interfaced to Elekta Treatment machines. An image enabled electronic medical record system used for oncology workflow management. Manufactured by: Impac Medical Systems 100 Mathilda Place, 5th floor Sunnyvale, Ca 94086

    Reason

    Impac Medical became aware of a problem with the recording of the Wedge Motor Units in MOSAIQ when it resumes after a machine terminates/faults, the remaining Wedge MU was being erroneously set to zero.

    Action

    A User Notice began being distributed on June 8, 2012. This will be followed by contact at each site by IMPAC support to determine if the site is affected by this issue, and if so, the upgraded version will be suggested. The Notice identified the affected device, the problem, the clinical impact, along with the interim mitigations and the final resolution. Users are encouraged to monitor daily delivery and recordings of treatments to be sure that the Wedge Motor Units treatments are properly delivered. The letter also recommends that treatment charts be checked weekly and that users not override any parameters in MOSAIQ until the machine setup has been completed. Users are to contact Elekta Support for the upgrade.

    Distribution

    Worldwide Distribution -- USA, including the states of VA, CT, GA, NJ and NY and the countries of Belgium, Denmark, France, and the United Kingdom.

    Quantity

    11 affected sites